Systems and methods allowing for reservoir air bubble management

ABSTRACT

Various embodiments of the present invention are directed to limiting a presence of air bubbles in fluidic media in a reservoir. Air passages may allow air to escape from fluidic media in a reservoir. Membranes may allow for trapping air bubbles in fluidic media before fluidic media enters a reservoir. A membrane may allow air to flow from a first reservoir containing fluidic media to a second reservoir while plunger heads within each of the reservoirs are moved within the reservoirs. An inner reservoir with a membrane may be moveable within an outer reservoir to allow air to move from the outer reservoir to the inner reservoir. An inner reservoir containing pressurized gas may allow fluidic media to be transferred to an outer reservoir.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

Embodiments of the present invention relate to U.S. ProvisionalApplication Ser. No. 60/927,032, filed Apr. 30, 2007, entitled “NeedleInserting, Reservoir Filling, Bubble Management, Fluid Flow Connectionsand Infusion Medium Delivery Systems and Methods with Same”, thecontents of which are incorporated by reference herein and which is abasis for a claim of priority.

Embodiments of the present invention relate to PCT InternationalApplication No. PCT/US2007/076641, filed Aug. 23, 2007, the contents ofwhich are incorporated by reference herein, and which claims the benefitof U.S. Provisional Application Ser. No. 60/927,032, filed Apr. 30,2007.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of the present invention relate generally to systems andmethods with reservoirs and, in specific embodiments, to systems andmethods allowing for reservoir air bubble management.

2. Related Art

According to modern medical techniques, certain chronic diseases may betreated by delivering a medication or other substance to the body of apatient. For example, diabetes is a chronic disease that is commonlytreated by delivering defined amounts of insulin to a patient atappropriate times. Traditionally, manually operated syringes and insulinpens have been employed for delivering insulin to a patient. Morerecently, modern systems have been designed to include programmablepumps for delivering controlled amounts of medication to a patient.

Pump type delivery devices have been configured in external devices,which connect to a patient, and have also been configured in implantabledevices, which are implanted inside of the body of a patient. Externalpump type delivery devices include devices designed for use in astationary location, such as a hospital, a clinic, or the like, andfurther include devices configured for ambulatory or portable use, suchas devices that are designed to be carried by a patient, or the like.External pump type delivery devices may be connected in fluid flowcommunication to a patient or user, for example, through a suitablehollow tubing. The hollow tubing may be connected to a hollow needlethat is designed to pierce the skin of the patient and to deliver afluidic medium there-through. Alternatively, the hollow tubing may beconnected directly to the patient as through a cannula, or the like.

Examples of some external pump type delivery devices are described inthe following references: (i) Published PCT Application WO 01/70307(PCT/US01/09139), entitled “Exchangeable Electronic Cards for InfusionDevices”; (ii) Published PCT Application WO 04/030716(PCT/US2003/028769), entitled “Components and Methods for PatientInfusion Device”; (iii) Published PCT Application WO 04/030717(PCT/US2003/029019), entitled “Dispenser Components and Methods forInfusion Device”; (iv) U.S. Patent Application Pub. No. 2005/0065760,entitled “Method for Advising Patients Concerning Doses Of Insulin”; and(v) U.S. Pat. No. 6,589,229, entitled “Wearable Self-Contained DrugInfusion Device”, each of which is incorporated by reference herein inits entirety.

As compared to syringes and insulin pens, pump type delivery devices canbe significantly more convenient to a patient, in that doses of insulinmay be calculated and delivered automatically to a patient at any timeduring the day or night. Furthermore, when used in conjunction withglucose sensors or monitors, insulin pumps may be automaticallycontrolled to provide appropriate doses of a fluidic medium atappropriate times of need, based on sensed or monitored levels of bloodglucose. As a result, pump type delivery devices have become animportant aspect of modern medical treatments of various types ofmedical conditions, such as diabetes, and the like. As pump technologiesimprove and doctors and patients become more familiar with such devices,external medical infusion pump treatments are expected to increase inpopularity and are expected to increase substantially in number over thenext decade.

SUMMARY OF THE DISCLOSURE

Various embodiments of the present invention are directed to limiting apresence of air bubbles in fluidic media in a reservoir. Air passagesmay allow air to escape from fluidic media in a reservoir. Membranes mayallow for trapping air bubbles in fluidic media before fluidic mediaenters a reservoir. A membrane may allow air to flow from a firstreservoir containing fluidic media to a second reservoir while plungerheads within each of the reservoirs are moved within the reservoirs. Aninner reservoir with a membrane may be moveable within an outerreservoir to allow air to move from the outer reservoir to the innerreservoir. An inner reservoir containing pressurized gas may allowfluidic media to be transferred to an outer reservoir.

A system for managing air bubbles in accordance with an embodiment ofthe present invention may include, but is not limited to, a reservoirand one or more filters. The reservoir may have an interior volume forcontaining fluidic media. The reservoir may have a port for expellingfluidic media from the interior volume of the reservoir. The reservoirmay have one or more air passages that extend from the interior volumeof the reservoir to an outer surface of the reservoir. Each of the oneor more filters may be located in a respective air passage of the one ormore air passages.

In various embodiments, each of the one or more filters may be locatedat an end of the respective air passage of the one or more air passages.In some embodiments, each of the one or more filters may comprise ahydrophobic material. Each of the one or more filters may be positionedat the end of the respective air passage of the one or more air passagesso as to substantially prevent fluidic media from entering therespective air passage of the one or more air passages in a case wherefluidic media is in the interior volume of the reservoir.

In various embodiments, the reservoir may have a fluid channel thatleads from the interior volume of the reservoir to the port of thereservoir. The one or more air passages may surround the fluid channelof the reservoir. Additionally, in various embodiments, each of the oneor more filters may be configured to allow air in the interior volume ofthe reservoir to pass through the filter and to exit the reservoirthrough the respective air passage of the one or more air passages. Insome embodiments, each of the one or more air passages may exit thereservoir on a same side of the reservoir where the port of thereservoir is located. In some embodiments, each of the one or more airpassages may allow air to exit the reservoir on a same side of thereservoir where fluidic media is expelled from the reservoir.

A method of making a system for managing air bubbles in accordance withan embodiment of the present invention may include, but is not limitedto, (i) providing a reservoir having an interior volume for containingfluidic media, the reservoir having a port for expelling fluidic mediafrom the interior volume of the reservoir, the reservoir having one ormore air passages that extend from the interior volume of the reservoirto an outer surface of the reservoir and (ii) locating each of one ormore filters in a respective air passage of the one or more airpassages.

In an embodiment for a system for managing air bubbles, the system mayinclude, but is not limited to, a reservoir, a plunger head, and amembrane. The plunger head may be moveable within the reservoir. Thereservoir may have an interior volume for containing fluidic media onone side of the plunger head. The reservoir may have a chamber on anopposite side of the plunger head from the interior volume of thereservoir. The reservoir may have a channel connecting the interiorvolume of the reservoir with the chamber of the reservoir. The membranemay be for allowing air to pass from the interior volume of thereservoir to the chamber of the reservoir through the channel of thereservoir and for inhibiting fluidic media from passing from theinterior volume of the reservoir to the chamber of the reservoir throughthe channel of the reservoir.

In various embodiments, the system may include a bias member connectedbetween a surface of the reservoir and the plunger head within thechamber of the reservoir. In some embodiments, the bias member maycomprise a spring.

In various embodiments, the system may include a valve for allowing avacuum to be applied to the chamber of the reservoir. In variousembodiments, the membrane may comprise a hydrophobic material.

A method of making a system for managing air bubbles in accordance withan embodiment of the present invention may include, but is not limitedto, (i) providing a reservoir, (ii) locating a plunger head moveablewithin the reservoir, the reservoir having a interior volume forcontaining fluidic media on one side of the plunger head, the reservoirhaving a chamber on an opposite side of the plunger head from theinterior volume of the reservoir, the reservoir having a channelconnecting the interior volume of the reservoir with the chamber of thereservoir, and (iii) providing a membrane for allowing air to pass fromthe interior volume of the reservoir to the chamber of the reservoirthrough the channel of the reservoir and for inhibiting fluidic mediafrom passing from the interior volume of the reservoir to the chamber ofthe reservoir through the channel of the reservoir.

In an embodiment for a system for managing air bubbles, the system mayinclude, but is not limited to, a reservoir, a plunger head, a bellowsmember, and a membrane. The reservoir may have an interior volume forcontaining fluidic media. The plunger head may be moveable within thereservoir. The plunger head may have a channel from a first surface ofthe plunger head to a second surface of the plunger head. The firstsurface of the plunger head may be contact with fluidic media in a casewhere fluidic media is in the interior volume of the reservoir. Thebellows member may be connected to the plunger head. The membrane may belocated within the channel of the plunger head. The membrane may beconfigured to allow air to pass from the interior volume of thereservoir to an interior volume of the bellows member through thechannel of the plunger head. The membrane may be configured to inhibitfluidic media from passing from the interior volume of the reservoir tothe interior volume of the bellows member through the channel of theplunger head in a case where fluidic media is in the interior volume ofthe reservoir.

A method of making a system for managing air bubbles in accordance withan embodiment of the present invention may include, but is not limitedto, (i) providing a reservoir having an interior volume for containingfluidic media, (ii) locating a plunger head moveable within thereservoir, the plunger head having a channel from a first surface of theplunger head to a second surface of the plunger head, the first surfaceof the plunger head in contact with fluidic media in a case wherefluidic media is in the interior volume of the reservoir, (iii)providing a bellows member connected to the plunger head, and (iv)locating a membrane within the channel of the plunger head, the membraneconfigured to allow air to pass from the interior volume of thereservoir to an interior volume of the bellows member through thechannel of the plunger head, the membrane configured to inhibit fluidicmedia from passing from the interior volume of the reservoir to theinterior volume of the bellows member through the channel of the plungerhead in a case where fluidic media is in the interior volume of thereservoir.

In an embodiment for a system for managing air bubbles, the system mayinclude, but is not limited to, a first reservoir, a first plunger head,a second reservoir, a second plunger head, and a membrane. The firstreservoir may have an interior volume for containing fluidic media. Thefirst plunger head may be moveable within the first reservoir. Thesecond reservoir may have an interior volume for containing air. Thefirst reservoir and the second reservoir may have a passage connectingthe interior volume of the first reservoir and the interior volume ofthe second reservoir. The second plunger head may be moveable within thesecond reservoir. The membrane may be for allowing air to pass from theinterior volume of the first reservoir to the interior volume of thesecond reservoir through the passage and for inhibiting fluidic mediafrom passing from the interior volume of the first reservoir to theinterior volume of the second reservoir through the passage.

In various embodiments, the first plunger head and the second plungerhead may be configured to move substantially simultaneously. In someembodiments, the second plunger head may be operatively connected to thefirst plunger head.

In various embodiments, the first reservoir may have a septum pierceableby a needle for providing a fluid path between a vial containing fluidicmedia and the interior volume of the first reservoir. In someembodiments, the first plunger head may be moveable within the firstreservoir between at least a first position and a second position. Thefirst plunger head may be for drawing fluidic media from the vial intothe interior volume of the first reservoir in a case where the vial isconnected to the first reservoir and the first plunger head is moved tothe second position of the first plunger head.

In various embodiments, the second plunger head may be moveable withinthe second reservoir between at least a first position and a secondposition. The membrane may be configured to allow air to pass from theinterior volume of the first reservoir through the passage to theinterior volume of the second reservoir in a case where air is in theinterior volume of the first reservoir and the second plunger head ismoved to the second position of the second plunger head.

In various embodiments, the interior volume of the second reservoir maybe located on one side of the second plunger head. The second reservoirmay have a chamber on an opposite side of the second plunger head fromthe interior volume of the second reservoir. The second reservoir mayhave a port for expelling air from the interior volume of the secondreservoir in a case where the interior volume of the second reservoircontains air and the port of the second reservoir and the interiorvolume of the second reservoir are in communication. In variousembodiments, the membrane may comprise a hydrophobic membrane.

A method of making a system for managing air bubbles in accordance withan embodiment of the present invention may include, but is not limitedto, (i) providing a first reservoir having an interior volume forcontaining fluidic media, (ii) locating a first plunger head moveablewithin the first reservoir, (iii) providing a second reservoir having aninterior volume for containing air, the first reservoir and the secondreservoir having a passage connecting the interior volume of the firstreservoir and the interior volume of the second reservoir, (iv) locatinga second plunger head moveable within the second reservoir, and (v)providing a membrane for allowing air to pass from the interior volumeof the first reservoir to the interior volume of the second reservoirthrough the passage and for inhibiting fluidic media from passing fromthe interior volume of the first reservoir to the interior volume of thesecond reservoir through the passage.

In an embodiment for a system for managing air bubbles, the system mayinclude, but is not limited to, an outer reservoir, an inner reservoir,a plunger head, and a membrane. The outer reservoir may have an interiorvolume for containing fluidic media. The inner reservoir may have aninterior volume. At least a portion of the inner reservoir may beconfigured to be moveable in the outer reservoir. The plunger head maybe moveable within the inner reservoir. The membrane may be for allowingair to pass from the interior volume of the outer reservoir to theinterior volume of the inner reservoir and for inhibiting fluidic mediafrom passing from the interior volume of the outer reservoir to theinterior volume of the inner reservoir.

In various embodiments, the plunger head may be moveable within theinner reservoir between at least a first plunger position and a secondplunger position. A vacuum in the interior volume of the inner reservoirmay be created when the plunger head is moved from the first plungerposition to the second plunger position. In some embodiments, the outerreservoir may have a septum pierceable by a needle for providing a fluidpath from a vial containing fluidic media to the interior volume of theouter reservoir.

In further embodiments, the inner reservoir may be configured to bemoveable in the outer reservoir between at least a first inner reservoirposition and a second inner reservoir position. Fluidic media may bedrawn from the vial into the interior volume of the outer reservoir in acase where the interior volume of the outer reservoir is in fluidcommunication with the vial and the inner reservoir is moved from thefirst inner reservoir position to the second inner reservoir position.In various embodiments, the membrane comprises a hydrophobic filter.

A method of making a system for managing air bubbles in accordance withan embodiment of the present invention may include, but is not limitedto, (i) providing an outer reservoir having an interior volume forcontaining fluidic media, (ii) providing an inner reservoir having aninterior volume, at least a portion of the inner reservoir configured tobe moveable in the outer reservoir, (iii) locating a plunger headmoveable within the inner reservoir, and (iv) providing a membrane forallowing air to pass from the interior volume of the outer reservoir tothe interior volume of the inner reservoir and for inhibiting fluidicmedia from passing from the interior volume of the outer reservoir tothe interior volume of the inner reservoir.

In an embodiment for a system for transferring fluidic media, the systemmay include, but is not limited to, an outer reservoir and an innerreservoir. The outer reservoir may have an interior volume forcontaining fluidic media. The inner reservoir may have an interiorvolume. The inner reservoir may have a septum pierceable by a needle.The needle may be for providing a path from a vial containing fluidicmedia to the interior volume of the inner reservoir in a case where afirst end of the needle is in contact with fluidic media in the vial anda second end of the needle opposite the first end of the needle is inthe interior volume of the inner reservoir. The outer reservoir may havea septum pierceable by the needle. The needle may be for providing afluid path from the vial containing fluidic media to the interior volumeof the outer reservoir in a case where the first end of the needle is incontact with fluidic media in the vial and the second end of the needleis in the interior volume of the outer reservoir. At least a portion ofthe inner reservoir may be configured to be moveable in the outerreservoir between at least a first inner reservoir position and a secondinner reservoir position

In various embodiments, the inner reservoir may be in the first innerreservoir position when the second end of the needle is in the interiorvolume of the inner reservoir. The inner reservoir may be in the secondinner reservoir position when the second end of the needle is in theinterior volume of the outer reservoir.

In various embodiments, pressure in the interior volume of the innerreservoir may be substantially equal to pressure in the vial when theinner reservoir is in the first inner reservoir position. In someembodiments, pressure in the vial may be greater than pressure in theinterior volume of the outer reservoir when the inner reservoir is inthe second inner reservoir position.

A method of making a system for transferring fluidic media in accordancewith an embodiment of the present invention may include, but is notlimited to, (i) providing an outer reservoir having an interior volumefor containing fluidic media, (ii) providing an inner reservoir havingan interior volume, the inner reservoir having a septum pierceable by aneedle, the needle for providing a path from a vial containing fluidicmedia to the interior volume of the inner reservoir in a case where afirst end of the needle is in contact with fluidic media in the vial anda second end of the needle opposite the first end of the needle is inthe interior volume of the inner reservoir, (iii) configuring the outerreservoir to include a septum pierceable by the needle, the needle forproviding a fluid path from the vial containing fluidic media to theinterior volume of the outer reservoir in a case where the first end ofthe needle is in contact with fluidic media in the vial and the secondend of the needle is in the interior volume of the outer reservoir, and(iv) configuring at least a portion of the inner reservoir to bemoveable in the outer reservoir between at least a first inner reservoirposition and a second inner reservoir position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a generalized representation of a system inaccordance with an embodiment of the present invention;

FIG. 2 illustrates an example of a system in accordance with anembodiment of the present invention;

FIG. 3 illustrates an example of a delivery device in accordance with anembodiment of the present invention;

FIG. 4 illustrates a delivery device in accordance with an embodiment ofthe present invention;

FIG. 5A illustrates a durable portion of a delivery device in accordancewith an embodiment of the present invention;

FIG. 5B illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 5C illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6A illustrates a disposable portion of a delivery device inaccordance with an embodiment of the present invention;

FIG. 6B illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6C illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 7 illustrates a cross-sectional view of a system for managing airbubbles in accordance with an embodiment of the present invention;

FIG. 8 illustrates a cross-sectional view of a system for managing airbubbles in accordance with an embodiment of the present invention;

FIG. 9 illustrates a cross-sectional view of a system for managing airbubbles in accordance with an embodiment of the present invention;

FIG. 10A illustrates a cross-sectional view of a system for managing airbubbles in accordance with an embodiment of the present invention;

FIG. 10B illustrates a cross-sectional view of a system for managing airbubbles in accordance with an embodiment of the present invention;

FIG. 11A illustrates a cross-sectional view of a system for managing airbubbles in accordance with an embodiment of the present invention;

FIG. 11B illustrates a cross-sectional view of a system for managing airbubbles in accordance with an embodiment of the present invention;

FIG. 11C illustrates a cross-sectional view of a system for managing airbubbles in accordance with an embodiment of the present invention;

FIG. 12A illustrates a cross-sectional view of a system for managing airbubbles in accordance with an embodiment of the present invention;

FIG. 12B illustrates a cross-sectional view of a portion of a system formanaging air bubbles in accordance with an embodiment of the presentinvention;

FIG. 13A illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 13B illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;and

FIG. 13C illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 illustrates a generalized representation of a system 10 inaccordance with an embodiment of the present invention. The system 10includes a delivery device 12. The system 10 may further include asensing device 14, a command control device (CCD) 16, and a computer 18.In various embodiments, the delivery device 12 and the sensing device 14may be secured at desired locations on the body 5 of a patient oruser-patient 7. The locations at which the delivery device 12 and thesensing device 14 are secured to the body 5 of the user-patient 7 inFIG. 1 are provided only as representative, non-limiting, examples.

The system 10, delivery device 12, sensing device 14, CCD 16 andcomputer 18 may be similar to those described in the following U.S.patent applications that were assigned to the assignee of the presentinvention, however, with a reservoir and plunger configuration such asdescribed herein with reference to FIGS. 7-8C, where each of followingpatent applications is incorporated herein by reference in its entirety:(i) U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005,“Infusion Device And Method With Disposable Portion”; (ii) U.S. patentapplication Ser. No. 11/515,225, filed Sep. 1, 2006, “Infusion MediumDelivery Device And Method With Drive Device For Driving Plunger InReservoir”; (iii) U.S. patent application Ser. No. 11/588,875, filedOct. 27, 2006, “Systems And Methods Allowing For Reservoir Filling AndInfusion Medium Delivery”; (iv) U.S. patent application Ser. No.11/588,832, filed Oct. 27, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (v) U.S.patent application Ser. No. 11/588,847, filed Oct. 27, 2006, “InfusionMedium Delivery Device And Method With Compressible Or Curved ReservoirOr Conduit”; (vi) U.S. patent application Ser. No. 11/589,323, filedOct. 27, 2006, “Infusion Pumps And Methods And Delivery Devices AndMethods With Same”; (vii) U.S. patent application Ser. No. 11/602,173,filed Nov. 20, 2006, “Systems And Methods Allowing For Reservoir FillingAnd Infusion Medium Delivery”; (viii) U.S. patent application Ser. No.11/602,052, filed Nov. 20, 2006, “Systems And Methods Allowing ForReservoir Filling And Infusion Medium Delivery”; (ix) U.S. patentapplication Ser. No. 11/602,428, filed Nov. 20, 2006, “Systems AndMethods Allowing For Reservoir Filling And Infusion Medium Delivery”;(x) U.S. patent application Ser. No. 11/602,113, filed Nov. 20, 2006,“Systems And Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (xi) U.S. patent application Ser. No. 11/604,171, filed Nov.22, 2006, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (xii) U.S. patent application Ser.No. 11/604,172, filed Nov. 22, 2006, “Infusion Medium Delivery DeviceAnd Method With Drive Device For Driving Plunger In Reservoir”; (xiii)U.S. patent application Ser. No. 11/606,703, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;(xiv) U.S. patent application Ser. No. 11/606,836, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;U.S. patent application Ser. No. 11/636,384, filed Dec. 8, 2006,“Infusion Medium Delivery Device And Method With Compressible Or CurvedReservoir Or Conduit”; (xv) U.S. patent application Ser. No. 11/645,993,filed Dec. 26, 2006, “Infusion Medium Delivery Device And Method WithCompressible Or Curved Reservoir Or Conduit”; U.S. patent applicationSer. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xvi) U.S. patent application Ser. No. 11/646,052,filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And MethodWith Needle Inserter And Needle Inserter Device And Method”; (xvii) U.S.patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “InfusionMedium Delivery System, Device And Method With Needle Inserter AndNeedle Inserter Device And Method”; (xviii) U.S. patent application Ser.No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; and (xix) U.S. patent application Ser. No. 11/759,725, filedJun. 7, 2007, “Infusion Medium Delivery Device And Method With DriveDevice For Driving Plunger In Reservoir”. In other embodiments, thesystem 10, delivery device 12, sensing device 14, CCD 16, and computer18 may have other suitable configurations.

The delivery device 12 is configured to deliver fluidic media to thebody 5 of the user-patient 7. In various embodiments, fluidic mediaincludes a liquid, a fluid, a gel, or the like. In some embodiments,fluidic media includes a medicine or a drug for treating a disease or amedical condition. For example, fluidic media may include insulin fortreating diabetes, or may include a drug for treating pain, cancer, apulmonary disorder, HIV, or the like. In some embodiments, fluidic mediaincludes a nutritional supplement, a dye, a tracing medium, a salinemedium, a hydration medium, or the like.

The sensing device 14 includes a sensor, a monitor, or the like, forproviding sensor data or monitor data. In various embodiments, thesensing device 14 may be configured to sense a condition of theuser-patient 7. For example, the sensing device 14 may includeelectronics and enzymes reactive to a biological condition, such as ablood glucose level, or the like, of the user-patient 7. In variousembodiments, the sensing device 14 may be secured to the body 5 of theuser-patient 7 or embedded in the body 5 of the user-patient 7 at alocation that is remote from the location at which the delivery device12 is secured to the body 5 of the user-patient 7. In various otherembodiments, the sensing device 14 may be incorporated within thedelivery device 12.

In further embodiments, the sensing device 14 and/or the delivery device12 may utilize a closed-loop system. Examples of sensing devices and/ordelivery devices utilizing closed-loop systems may be found at, but arenot limited to, the following references: (i) U.S. Pat. No. 6,088,608,entitled “Electrochemical Sensor And Integrity Tests Therefor”; (ii)U.S. Pat. No. 6,119,028, entitled “Implantable Enzyme-Based MonitoringSystems Having Improved Longevity Due To Improved Exterior Surfaces”;(iii) U.S. Pat. No. 6,589,229, entitled “Implantable Enzyme-BasedMonitoring Systems Adapted for Long Term Use”; (iv) U.S. Pat. No.6,740,072, entitled “System And Method For Providing Closed LoopInfusion Formulation Delivery”; (v) U.S. Pat. No. 6,827,702, entitled“Safety Limits For Closed-Loop Infusion Pump Control”; (vi) U.S. Pat.No. 7,323,142, entitled “Sensor Substrate And Method Of FabricatingSame”; (vii) U.S. patent application Ser. No. 09/360,342, filed Jul. 22,1999, entitled “Substrate Sensor”; and (viii) U.S. Provisional PatentApplication Ser. No. 60/318,060, filed Sep. 7, 2001, entitled “SensingApparatus and Process”, all of which are incorporated herein byreference in their entirety.

In such embodiments, the sensing device 14 may be configured to sense acondition of the user-patient 7, such as, but not limited to, bloodglucose level, or the like. The delivery device 12 may be configured todeliver fluidic media in response to the condition sensed by the sensingdevice 14. In turn, the sensing device 14 may continue to sense a newcondition of the user-patient, allowing the delivery device 12 todeliver fluidic media continuously in response to the new conditionsensed by the sensing device 14 indefinitely. In other embodiments, thesensing device 14 and/or the delivery device 12 may be configured toutilize the closed-loop system only for a portion of the day, forexample only when the user-patient is asleep or awake.

Each of the delivery device 12, the sensing device 14, the CCD 16, andthe computer 18 may include transmitter, receiver, or transceiverelectronics that allow for communication with other components of thesystem 10. The sensing device 14 may be configured to transmit sensordata or monitor data to the delivery device 12. The sensing device 14may also be configured to communicate with the CCD 16. The deliverydevice 12 may include electronics and software that are configured toanalyze sensor data and to deliver fluidic media to the body 5 of theuser-patient 7 based on the sensor data and/or preprogrammed deliveryroutines.

The CCD 16 and the computer 18 may include electronics and othercomponents configured to perform processing, delivery routine storage,and to control the delivery device 12. By including control functions inthe CCD 16 and/or the computer 18, the delivery device 12 may be madewith more simplified electronics. However, in some embodiments, thedelivery device 12 may include all control functions, and may operatewithout the CCD 16 and the computer 18. In various embodiments, the CCD16 may be a portable electronic device. Also, in various embodiments,the delivery device 12 and/or the sensing device 14 may be configured totransmit data to the CCD 16 and/or the computer 18 for display orprocessing of the data by the CCD 16 and/or the computer 18.

Examples of the types of communications and/or control capabilities, aswell as device feature sets and/or program options may be found in thefollowing references: (i) U.S. patent application Ser. No. 10/445,477,filed May 27, 2003, entitled “External Infusion Device with RemoteProgramming, Bolus Estimator and/or Vibration Alarm Capabilities”; (ii)U.S. patent application Ser. No. 10/429,385, filed May 5, 2003, entitled“Handheld Personal Data Assistant (PDA) with a Medical Device and Methodof Using the Same”; and (iii) U.S. patent application Ser. No.09/813,660, filed Mar. 21, 2001, entitled “Control Tabs for InfusionDevices and Methods of Using the Same”, all of which are incorporatedherein by reference in their entirety.

FIG. 2 illustrates an example of the system 10 in accordance with anembodiment of the present invention. The system 10 in accordance withthe embodiment illustrated in FIG. 2 includes the delivery device 12 andthe sensing device 14. The delivery device 12 in accordance with anembodiment of the present invention includes a disposable housing 20, adurable housing 30, and a reservoir system 40. The delivery device 12may further include an infusion path 50.

Elements of the delivery device 12 that ordinarily contact the body of auser-patient or that ordinarily contact fluidic media during operationof the delivery device 12 may be considered as a disposable portion ofthe delivery device 12. For example, a disposable portion of thedelivery device 12 may include the disposable housing 20 and thereservoir system 40. The disposable portion of the delivery device 12may be recommended for disposal after a specified number of uses.

On the other hand, elements of the delivery device 12 that do notordinarily contact the body of the user-patient or fluidic media duringoperation of the delivery device 12 may be considered as a durableportion of the delivery device 12. For example, a durable portion of thedelivery device 12 may include the durable housing 30, electronics (notshown in FIG. 2), a drive device having a motor and drive linkage (notshown in FIG. 2), and the like. Elements of the durable housing portionof the delivery device 12 are typically not contaminated from contactwith the user-patient or fluidic media during normal operation of thedelivery device 12 and, thus, may be retained for re-use with replaceddisposable portions of the delivery device 12.

In various embodiments, the disposable housing 20 supports the reservoirsystem 40 and has a bottom surface (facing downward and into the page inFIG. 2) that is configured to secure to the body of a user-patient. Anadhesive may be employed at an interface between the bottom surface ofthe disposable housing 20 and the skin of a user-patient, so as toadhere the disposable housing 20 to the skin of the user-patient. Invarious embodiments, the adhesive may be provided on the bottom surfaceof the disposable housing 20, with a peelable cover layer covering theadhesive material. In this manner, the cover layer may be peeled off toexpose the adhesive material, and the adhesive side of the disposablehousing 20 may be placed against the user-patient, for example againstthe skin of the user-patient. Thus in some embodiments, the deliverydevice 12 may be attached to the skin of the user-patient.

In other embodiments, the disposable housing 20 and/or the remainingportions of the delivery device 12 may be worn or otherwise attached onor underneath clothing of the user-patient. Similarly, the deliverydevice 12 may be supported by any suitable manner, such as, but notlimited to, on a belt, in a pocket, and the like. Representativeexamples of such delivery devices 12 may include, but is not limited to,the MiniMed Paradigm 522 Insulin Pump, MiniMed Paradigm 722 InsulinPump, MiniMed Paradigm 515 Insulin Pump, MiniMed Paradigm 715 InsulinPump, MiniMed Paradigm 512R Insulin Pump, MiniMed Paradigm 712R InsulinPump, MiniMed 508 Insulin Pump, MiniMed 508R Insulin Pump, and any otherderivatives thereof.

The reservoir system 40 is configured for containing or holding fluidicmedia, such as, but not limited to insulin. In various embodiments, thereservoir system 40 includes a hollow interior volume for receivingfluidic media, such as, but not limited to, a cylinder-shaped volume, atubular-shaped volume, or the like. In some embodiments, the reservoirsystem 40 may be provided as a cartridge or canister for containingfluidic media. In various embodiments, the reservoir system 40 is ableto be refilled with fluidic media. In further embodiments, the reservoirsystem 40 is pre-filled with fluidic media.

The reservoir system 40 may be supported by the disposable housing 20 inany suitable manner. For example, the disposable housing 20 may beprovided with projections or struts (not shown), or a trough feature(not shown), for holding the reservoir system 40. In some embodiments,the reservoir system 40 may be supported by the disposable housing 20 ina manner that allows the reservoir system 40 to be removed from thedisposable housing 20 and replaced with another reservoir.Alternatively, or in addition, the reservoir system 40 may be secured tothe disposable housing 20 by a suitable adhesive, a strap, or othercoupling structure.

In various embodiments, the reservoir system 40 includes a port 41 forallowing fluidic media to flow into and/or flow out of the interiorvolume of the reservoir system 40. In some embodiments, the infusionpath 50 includes a connector 56, a tube 54, and a needle apparatus 52.The connector 56 of the infusion path 50 may be connectable to the port41 of the reservoir system 40. In various embodiments, the disposablehousing 20 is configured with an opening near the port 41 of thereservoir system 40 for allowing the connector 56 of the infusion path50 to be selectively connected to and disconnected from the port 41 ofthe reservoir system 40.

In various embodiments, the port 41 of the reservoir system 40 iscovered with or supports a septum (not shown in FIG. 2), such as aself-sealing septum, or the like. The septum may be configured toprevent fluidic media from flowing out of the reservoir system 40through the port 41 when the septum is not pierced. Also, in variousembodiments, the connector 56 of the infusion path 50 includes a needlefor piercing the septum covering the port 41 of the reservoir system 40so as to allow fluidic media to flow out of the interior volume of thereservoir system 40.

Examples of needle/septum connectors can be found in U.S. patentapplication Ser. No. 10/328,393, filed Dec. 22, 2003, entitled“Reservoir Connector”, which is incorporated herein by reference in itsentirety. In other alternatives, non-septum connectors such as Luerlocks, or the like may be used. In various embodiments, the needleapparatus 52 of the infusion path 50 includes a needle that is able topuncture the skin of a user-patient. Also, in various embodiments, thetube 54 connects the connector 56 with the needle apparatus 52 and ishollow, such that the infusion path 50 is able to provide a path toallow for the delivery of fluidic media from the reservoir system 40 tothe body of a user-patient.

The durable housing 30 of the delivery device 12 in accordance withvarious embodiments of the present invention includes a housing shellconfigured to mate with and secure to the disposable housing 20. Thedurable housing 30 and the disposable housing 20 may be provided withcorrespondingly shaped grooves, notches, tabs, or other suitablefeatures, that allow the two parts to easily connect together, bymanually pressing the two housings together, by twist or threadedconnection, or other suitable manner of connecting the parts that iswell known in the mechanical arts.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be connected to each other using a twist action. Thedurable housing 30 and the disposable housing 20 may be configured to beseparable from each other when a sufficient force is applied todisconnect the two housings from each other. For example, in someembodiments the disposable housing 20 and the durable housing 30 may besnapped together by friction fitting. In various embodiments, a suitableseal, such as an o-ring seal, may be placed along a peripheral edge ofthe durable housing 30 and/or the disposable housing 20, so as toprovide a seal against water entering between the durable housing 30 andthe disposable housing 20.

The durable housing 30 of the delivery device 12 may support a drivedevice (not shown in FIG. 2), including a motor and a drive devicelinkage portion, for applying a force to fluidic media within thereservoir system 40 to force fluidic media out of the reservoir system40 and into an infusion path, such as the infusion path 50, for deliveryto a user-patient. For example, in some embodiments, an electricallydriven motor may be mounted within the durable housing 30 withappropriate linkage for operatively coupling the motor to a plunger arm(not shown in FIG. 2) connected to a plunger head (not shown in FIG. 2)that is within the reservoir system 40 and to drive the plunger head ina direction to force fluidic media out of the port 41 of the reservoirsystem 40 and to the user-patient.

Also, in some embodiments, the motor may be controllable to reversedirection so as to move the plunger arm and the plunger head to causefluid to be drawn into the reservoir system 40 from a patient. The motormay be arranged within the durable housing 30 and the reservoir system40 may be correspondingly arranged on the disposable housing 20, suchthat the operable engagement of the motor with the plunger head, throughthe appropriate linkage, occurs automatically upon the user-patientconnecting the durable housing 30 with the disposable housing 20 of thedelivery device 12. Further examples of linkage and control structuresmay be found in U.S. patent application Ser. No. 09/813,660, filed Mar.21, 2001, entitled “Control Tabs for Infusion Devices and Methods ofUsing the Same”, which is incorporated herein by reference in itsentirety.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be made of suitably rigid materials that maintain theirshape, yet provide sufficient flexibility and resilience to effectivelyconnect together and disconnect, as described above. The material of thedisposable housing 20 may be selected for suitable compatibility withskin. For example, the disposable housing 20 and the durable housing 30of the delivery device 12 may be made of any suitable plastic, metal,composite material, or the like. The disposable housing 20 may be madeof the same type of material or a different material relative to thedurable housing 30. In some embodiments, the disposable housing 20 andthe durable housing 30 may be manufactured by injection molding or othermolding processes, machining processes, or combinations thereof.

For example, the disposable housing 20 may be made of a relativelyflexible material, such as a flexible silicone, plastic, rubber,synthetic rubber, or the like. By forming the disposable housing 20 of amaterial capable of flexing with the skin of a user-patient, a greaterlevel of user-patient comfort may be achieved when the disposablehousing 20 is secured to the skin of the user-patient. Also, a flexibledisposable housing 20 may result in an increase in site options on thebody of the user-patient at which the disposable housing 20 may besecured.

In the embodiment illustrated in FIG. 2, the delivery device 12 isconnected to the sensing device 14 through a connection element 16 ofthe sensing device 14. The sensing device 14 may include a sensor 15that includes any suitable biological or environmental sensing device,depending upon a nature of a treatment to be administered by thedelivery device 12. For example, in the context of delivering insulin toa diabetes patient, the sensor 15 may include a blood glucose sensor, orthe like.

In some embodiments, the sensor 15 may include a continuous glucosesensor. The continuous glucose sensor may be implantable within the bodyof the user-patient. In other embodiments, the continuous glucose sensormay be located externally, for example on the skin of the user-patient,or attached to clothing of the user-patient. In such embodiments, fluidmay be drawn continually from the user-patient and sensed by thecontinuous glucose sensor. In various embodiments, the continuousglucose sensor may be configured to sense and/or communicate with theCCD 16 continuously. In other embodiments, the continuous glucose sensormay be configured to sense and/or communicate with the CCD 16intermittently, for example sense glucose levels and transmitinformation every few minutes. In various embodiments, the continuousglucose sensor may utilize glucose oxidase.

The sensor 15 may be an external sensor that secures to the skin of auser-patient or, in other embodiments, may be an implantable sensor thatis located in an implant site within the body of the user-patient. Infurther alternatives, the sensor may be included with as a part or alongside the infusion cannula and/or needle, such as for example as shown inU.S. patent application Ser. No. 11/149,119, filed Jun. 8, 2005,entitled “Dual Insertion Set”, which is incorporated herein by referencein its entirety. In the illustrated example of FIG. 2, the sensor 15 isan external sensor having a disposable needle pad that includes a needlefor piercing the skin of the user-patient and enzymes and/or electronicsreactive to a biological condition, such as blood glucose level or thelike, of the user-patient. In this manner, the delivery device 12 may beprovided with sensor data from the sensor 15 secured to the user-patientat a site remote from the location at which the delivery device 12 issecured to the user-patient.

While the embodiment shown in FIG. 2 includes a sensor 15 connected bythe connection element 16 for providing sensor data to sensorelectronics (not shown in FIG. 2) located within the durable housing 30of the delivery device 12, other embodiments may employ a sensor 15located within the delivery device 12. Yet other embodiments may employa sensor 15 having a transmitter for communicating sensor data by awireless communication link with receiver electronics (not shown in FIG.2) located within the durable housing 30 of the delivery device 12. Invarious embodiments, a wireless connection between the sensor 15 and thereceiver electronics within the durable housing 30 of the deliverydevice 12 may include a radio frequency (RF) connection, an opticalconnection, or another suitable wireless communication link. Furtherembodiments need not employ the sensing device 14 and, instead, mayprovide fluidic media delivery functions without the use of sensor data.

As described above, by separating disposable elements of the deliverydevice 12 from durable elements, the disposable elements may be arrangedon the disposable housing 20, while durable elements may be arrangedwithin a separable durable housing 30. In this regard, after aprescribed number of uses of the delivery device 12, the disposablehousing 20 may be separated from the durable housing 30, so that thedisposable housing 20 may be disposed of in a proper manner. The durablehousing 30 may then be mated with a new (un-used) disposable housing 20for further delivery operation with a user-patient.

FIG. 3 illustrates an example of the delivery device 12 in accordancewith another embodiment of the present invention. The delivery device 12of the embodiment of FIG. 3 is similar to the delivery device 12 of theembodiment of FIG. 2. While the delivery device 12 in the embodimentillustrated in FIG. 2 provides for the durable housing 30 to cover thereservoir system 40, the delivery device 12 in the embodiment of FIG. 3provides for the durable housing 30 to secure to the disposable housing20 without covering the reservoir system 40. The delivery device 12 ofthe embodiment illustrated in FIG. 3 includes the disposable housing 20,and the disposable housing 20 in accordance with the embodimentillustrated in FIG. 3 includes a base 21 and a reservoir retainingportion 24. In one embodiment, the base 21 and reservoir retainingportion 24 may be formed as a single, unitary structure.

The base 21 of the disposable housing 20 is configured to be secured tothe body of a user-patient. The reservoir retaining portion 24 of thedisposable housing 20 is configured to house the reservoir system 40.The reservoir retaining portion 24 of the disposable housing 20 may beconfigured to have an opening to allow for the port 41 of the reservoirsystem 40 to be accessed from outside of the reservoir retaining portion24 while the reservoir system 40 is housed in the reservoir retainingportion 24. The durable housing 30 may be configured to be attachable toand detachable from the base 21 of the disposable housing 20. Thedelivery device 12 in the embodiment illustrated in FIG. 3 includes aplunger arm 60 that is connected to or that is connectable to a plungerhead (not shown in FIG. 3) within the reservoir system 40.

FIG. 4 illustrates another view of the delivery device 12 of theembodiment of FIG. 3. The delivery device 12 of the embodimentillustrated in FIG. 4 includes the disposable housing 20, the durablehousing 30, and the infusion path 50. The disposable housing 20 in theembodiment of FIG. 4 includes the base 21, the reservoir retainingportion 24, and a peelable cover layer 25. The peelable cover layer 25may cover an adhesive material on the bottom surface 22 of the base 21.The peelable cover layer 25 may be configured to be peelable by auser-patient to expose the adhesive material on the bottom surface 22 ofthe base 21. In some embodiments, there may be multiple adhesive layerson the bottom surface 22 of the base 21 that are separated by peelablelayers.

The infusion path 50 in accordance with the embodiment of the presentinvention illustrated in FIG. 4 includes the needle 58 rather than theconnector 56, the tube 54, and the needle apparatus 52 as shown in theembodiment of FIG. 2. The base 21 of the disposable housing 20 may beprovided with an opening or pierceable wall in alignment with a tip ofthe needle 58, to allow the needle 58 to pass through the base 21 andinto the skin of a user-patient under the base 21, when extended. Inthis manner, the needle 58 may be used to pierce the skin of theuser-patient and deliver fluidic media to the user-patient.

Alternatively, the needle 58 may be extended through a hollow cannula(not shown in FIG. 4), such that upon piercing the skin of theuser-patient with the needle 58, an end of the hollow cannula is guidedthrough the skin of the user-patient by the needle 58. Thereafter, theneedle 58 may be removed, leaving the hollow cannula in place, with oneend of the cannula located within the body of the user-patient and theother end of the cannula in fluid flow connection with fluidic mediawithin the reservoir system 40, to convey pumped infusion media from thereservoir system 40 to the body of the user-patient.

FIG. 5A illustrates a durable portion 8 of the delivery device 12 (referto FIG. 3) in accordance with an embodiment of the present invention.FIG. 5B illustrates a section view of the durable portion 8 inaccordance with an embodiment of the present invention. FIG. 5Cillustrates another section view of the durable portion 8 in accordancewith an embodiment of the present invention. With reference to FIGS. 5A,5B, and 5C, in various embodiments, the durable portion 8 includes thedurable housing 30, and a drive device 80. The drive device 80 includesa motor 84 and a drive device linkage portion 82.

In various embodiments, the durable housing 30 may include an interiorvolume for housing the motor 84, the drive device linkage portion 82,other electronic circuitry, and a power source (not shown in FIGS. 5A,5B, and 5C). Also, in various embodiments, the durable housing 30 isconfigured with an opening 32 for receiving a plunger arm 60 (refer toFIG. 3). Also, in various embodiments, the durable housing 30 mayinclude one or more connection members 34, such as tabs, insertionholes, or the like, for connecting with the base 21 of the disposablehousing 20 (refer to FIG. 3).

FIG. 6A illustrates a disposable portion 9 of the delivery device 12(refer to FIG. 3) in accordance with an embodiment of the presentinvention. FIG. 6B illustrates a section view of the disposable portion9 in accordance with an embodiment of the present invention. FIG. 6Cillustrates another section view of the disposable portion 9 inaccordance with an embodiment of the present invention. With referenceto FIGS. 6A, 6B, and 6C, in various embodiments, the disposable portion9 includes the disposable housing 20, the reservoir system 40, theplunger arm 60, and a plunger head 70. In some embodiments, thedisposable housing 20 includes the base 21 and the reservoir retainingportion 24. In various embodiments, the base 21 includes a top surface23 having one or more connection members 26, such as tabs, grooves, orthe like, for allowing connections with the one or more connectionmembers 34 of embodiments of the durable housing 30 (refer to FIG. 5B).

In various embodiments, the reservoir system 40 is housed within thereservoir retaining portion 24 of the disposable housing 20, and thereservoir system 40 is configured to hold fluidic media. Also, invarious embodiments, the plunger head 70 is disposed at least partiallywithin the reservoir system 40 and is moveable within the reservoirsystem 40 to allow fluidic media to fill into the reservoir system 40and to force fluidic media out of the reservoir system 40. In someembodiments, the plunger arm 60 is connected to or is connectable to theplunger head 70.

Also, in some embodiments, a portion of the plunger arm 60 extends tooutside of the reservoir retaining portion 24 of the disposable housing20. In various embodiments, the plunger arm 60 has a mating portion formating with the drive device linkage portion 82 of the drive device 80(refer to FIG. 5C). With reference to FIGS. 5C and 6C, in someembodiments, the durable housing 30 may be snap fitted onto thedisposable housing 20, whereupon the drive device linkage portion 82automatically engages the mating portion of the plunger arm 60.

When the durable housing 30 and the disposable housing 20 are fittedtogether with the drive device linkage portion 82 engaging or matingwith the plunger arm 60, the motor 84 may be controlled to drive thedrive device linkage portion 82 and, thus, move the plunger arm 60 tocause the plunger head 70 to move within the reservoir system 40. Whenthe interior volume of the reservoir system 40 is filled with fluidicmedia and an infusion path is provided from the reservoir system 40 tothe body of a user-patient, the plunger head 70 may be moved within thereservoir system 40 to force fluidic media from the reservoir system 40and into the infusion path, so as to deliver fluidic media to the bodyof the user-patient.

In various embodiments, once the reservoir system 40 has beensufficiently emptied or otherwise requires replacement, a user-patientmay simply remove the durable housing 30 from the disposable housing 20,and replace the disposable portion 9, including the reservoir system 40,with a new disposable portion having a new reservoir. The durablehousing 30 may be connected to the new disposable housing of the newdisposable portion, and the delivery device including the new disposableportion may be secured to the skin of a user-patient, or otherwiseattached to the user-patient.

In various other embodiments, rather than replacing the entiredisposable portion 9 every time the reservoir system 40 is emptied, thereservoir system 40 may be refilled with fluidic media. In someembodiments, the reservoir system 40 may be refilled while remainingwithin the reservoir retaining portion 24 (refer to FIG. 6B) of thedisposable housing 20. Also, in various embodiments, the reservoirsystem 40 may be replaced with a new reservoir (not shown), while thedisposable housing 20 may be re-used with the new reservoir. In suchembodiments, the new reservoir may be inserted into the disposableportion 9.

With reference to FIGS. 3, 5A, 6B, and 6C, in various embodiments, thedelivery device 12 includes reservoir status circuitry (not shown), andthe reservoir system 40 includes reservoir circuitry (not shown). Invarious embodiments, the reservoir circuitry stores information such as,but not limited to, at least one of (i) an identification stringidentifying the reservoir system 40; (ii) a manufacturer of thereservoir system 40; (iii) contents of the reservoir system 40; and (iv)an amount of contents in the reservoir system 40. In some embodiments,the delivery device 12 includes the reservoir status circuitry (notshown), and the reservoir status circuitry is configured to read datafrom the reservoir circuitry when the reservoir system 40 is insertedinto the disposable portion 9.

In various embodiments, the reservoir status circuitry is furtherconfigured to store data to the reservoir circuitry after at least someof the contents of the reservoir system 40 have been transferred out ofthe reservoir system 40, so as to update information in the reservoircircuitry related to an amount of contents still remaining in thereservoir system 40. In some embodiments, the reservoir status circuitryis configured to store data to the reservoir circuitry, so as to updateinformation in the reservoir circuitry related to an amount of contentsstill remaining in the reservoir system 40, when the reservoir system 40is inserted into the disposable portion 9. In some embodiments, thedelivery device 12 includes the reservoir status circuitry (not shown)and the reservoir system 40 includes the reservoir circuitry (notshown), and the reservoir status circuitry selectively inhibits use ofthe delivery device 12 or selectively provides a warning signal based oninformation read by the reservoir status circuitry from the reservoircircuitry.

FIG. 7 illustrates a cross-sectional view of a system 100 in accordancewith an embodiment of the present invention. The system 100 may include,but is not limited to, a reservoir 110, a plunger head 120, a plungerarm 130, a septum 140, one or more hydrophobic filters 171, and one ormore air passages 172. The reservoir 110 may have a hollow interior forcontaining fluidic media. The plunger head 120 may be located within thereservoir 110 and may be moveable in an axial direction of the reservoir110 to expand or contract an interior volume of the reservoir 110. Thereservoir may include a neck portion 112. The septum 140 may be locatedat an end of the neck portion 112 of the reservoir 110. A fluid channel150 may be defined in the neck portion 112 of the reservoir 110extending from the septum 140.

The one or more air passages 172 may extend from within the reservoir110 to a same outer surface of the reservoir 110 through which fluidicmedia is expelled from the reservoir 110. In various embodiments, theone or more air passages 172 may surround the fluid channel 150. The oneor more hydrophobic filters 171 may be located at ends of the one ormore air passages 172 within the reservoir 110. The hydrophobic filters171 may comprise hydrophobic material that may substantially preventfluidic media in the reservoir 110 from entering the one or more airpassages 172. The one or more air passages 172 may allow for air in thereservoir to pass through the one or more hydrophobic filters 171 and toexit the reservoir 110.

A method in accordance with the present invention allows for expellingfluidic media from the reservoir 110. In a first step of the method, afluid path may be established through the septum 140 to the fluidchannel 150. In a second step of the method, the plunger head 120 may bedepressed within the reservoir 110, such that fluidic media is expelledthrough the fluid channel 150 and out of the reservoir 110 through theseptum 140.

When fluidic media is being expelled through the fluid channel 150, airin the reservoir 110 may be able to pass through the one or morehydrophobic filters 171 and out of the reservoir 110 through the one ormore air passages 172. Fluidic media may be substantially prevented fromentering the one or more air passages 172 by the one or more hydrophobicfilters 171. Thus, in accordance with the method, fluidic media may beexpelled from the reservoir 110 while air in the reservoir 110 is ableto escape through the one or more air passages 172 that exit thereservoir 110 on a same side of the reservoir 110 that fluidic mediaexits the reservoir 110.

FIG. 8 illustrates a cross-sectional view of a system 200 in accordancewith an embodiment of the present invention. The system 200 may include,but is not limited to, a reservoir 210, a plunger head 220, a plungerarm 230, a septum 240, a membrane 252, a channel 254, a bias member,such as a spring 272, a seal 274, and a valve 276. The reservoir 210 mayhave a interior volume 282 for containing fluidic media between theplunger head 220 and the septum 240. The reservoir 210 may have achamber 284 on an opposite side of the plunger head 220 from theinterior volume 282 of the reservoir 210.

The plunger head 220 may be advanced within the reservoir 210 to expelfluidic media from the reservoir 210. The spring 272 may be connectedbetween a surface of the reservoir 210 and the plunger head 220 in thechamber 284 of the reservoir 210. The seal 274 may create asubstantially airtight seal around the plunger arm 230 in a locationwhere the plunger arm 230 exits the chamber 284 of the reservoir 210.The valve 276 may allow a vacuum to be applied to the chamber 284. Themembrane 252 may be located in an opening in a wall of the reservoir 210and air may be able to pass from the interior volume 282 of thereservoir 210 through the membrane 252 and through the channel 254 ofthe reservoir 210 into the chamber 284 of the reservoir 210. Themembrane 252 may comprise, for example, a hydrophobic material, or thelike.

In some embodiments, a vacuum may be applied to the chamber 284 of thereservoir 210 through the valve 276 to create a vacuum in the chamber284 of the reservoir 210, and then the valve 276 may be closed. Themembrane 252 and the channel 254 of the reservoir 210 may allow for atransfer of air bubbles from a fluidic media side of the plunger head220 to a back side of the plunger head 220. The membrane 252 maysubstantially prevent a loss of fluidic media through the channel 254 ofthe reservoir 210. A slight vacuum in the chamber 284 of the reservoir210 and an advancement of the plunger head 220 by the spring 272 maypromote a migration of air bubbles from the interior volume 282 of thereservoir 210 to the chamber 284 of the reservoir 210 through thechannel 254 of the reservoir 210.

Thus, embodiments of the present invention may allow for a vacuum in achamber of a reservoir behind a plunger head to pull or otherwise drawair out of an interior volume of the reservoir through a channel of thereservoir from the interior volume of the reservoir to the chamber ofthe reservoir. Such embodiments may allow for continuous degassing offluidic media in the interior volume of the reservoir.

FIG. 9 illustrates a cross-sectional view of a system 300 in accordancewith an embodiment of the present invention. The system 300 may include,but is not limited to, a reservoir 310, a plunger head 320, a plungerarm 330, a septum 340, a bellows member 372, a one-way valve 374, andone or more membranes 390. The plunger head 320 may be connected to theplunger arm 330, and the plunger head 320 may be moveable within thereservoir 310. The reservoir 310 may have an interior volume 382 forcontaining fluidic media between the plunger head 320 and the septum340. The septum 340 may be located at an exit port of the reservoir 310.

The bellows member 372 may be connected between a back surface 312 ofthe reservoir 310 and the plunger head 320. The bellows member 372 maybe connected to a backside of the plunger head 320 opposite from a sideof the plunger head 320 that contacts fluidic media. The bellows member372 may be sealed to the plunger head 320. The one or more membranes 390may be located on the side of the plunger head 320 in contact withfluidic media. The one or more membranes 390 may lead to channelsthrough the plunger head 320 that extend from the side of the plungerhead 320 in contact with fluidic media to the backside of the plungerhead 320.

The one or more membranes 390 may comprise, for example, a hydrophobicmaterial, or the like, that allows air to pass through, but maysubstantially prevent a passage of fluidic media through the one or moremembranes 390. Thus, air may be able to pass from the interior volume382 of the reservoir 310 through the one or more membranes 390 andthrough the plunger head 320 into an area 384 within the bellows member372. The bellows member 372 may be able to expand or contract with amovement of the plunger head 320. As the plunger head 320 is movedforward to deliver fluidic media, a vacuum may be generated in thebellows member 372 and, thus, air bubbles, vapor, or the like may bedrawn through the one or more membranes 390 and into the area 384 withinthe bellows member 372. When the reservoir 310 is completely filled, thebellows member 372 may be fully compressed, and the air in the bellowsmember 372 may be forced through the one-way valve 374.

FIGS. 10A and 10B illustrate a cross-sectional view of a system 400 inaccordance with an embodiment of the present invention. The system 400may include, but is not limited to, a first reservoir 410, a firstplunger head 420, a second reservoir 460, a second plunger head 470, anda membrane 452. The first plunger head 420 may be positioned within thefirst reservoir 410. The second plunger head 470 may be positionedwithin the second reservoir 460.

The first reservoir 410 may have a septum 440. The first reservoir 410may have an interior volume 482 for containing fluidic media on one sideof the first plunger head 420. The first reservoir 410 may have a firstchamber 484 on an opposite side of the first plunger head 420 from theinterior volume 482 of the first reservoir 410.

The second reservoir 460 may have an interior volume 486 on one side ofthe second plunger head 470. The interior volume 486 of the secondreservoir 460 may be for, but is not limited to, containing air, or thelike. The second reservoir 460 may have a second chamber 488 on anopposite side of the second plunger head 470 from the interior volume486 of the second reservoir 460.

The first plunger head 420 may be moveable in an axial direction withinthe first reservoir 410 to expand or contract the interior volume 482 ofthe first reservoir 410. Accordingly, a volume of the first chamber 484of the first reservoir 410 may contract while the interior volume 482 ofthe first reservoir 410 expands. The second plunger head 470 may bemoveable in an axial direction within the second reservoir 460 to expandor contract the interior volume 486 of the second reservoir 460.Accordingly, a volume of the second chamber 488 of the second reservoir460 may contract while the interior volume 486 of the second reservoir460 expands.

The first plunger head 420 may be connected to an end of a first plungerarm 430. The second plunger head 470 may be connected to an end of asecond plunger arm 432. The opposite ends of the first plunger arm 430and the second plunger arm 432 connected to the first plunger head 420and the second plunger head 470, respectively, may be operativelyconnected to each other, for example by a handle 435. In someembodiments, this may allow the first plunger head 420 and the secondplunger head 470 to be moved substantially simultaneously to oneanother.

The first reservoir 410 and the second reservoir 460 may have a passage454 connecting the interior volume 482 of the first reservoir 410 andthe interior volume 486 of the second reservoir 460. The membrane 452may be positioned in the passage 454. The membrane 452 may be configuredsuch that air may be able to pass from the interior volume 482 of thefirst reservoir 410 through the passage 454 and the membrane 452 intothe interior volume 486 of the second reservoir 460. The membrane 452may comprise, for example, a hydrophobic material, or the like.

The system 400 may include a vial 490 and a needle 492. The vial 490 maybe for containing fluidic media. The septum 440 of the first reservoir410 may be pierceable by the needle 492 to provide a fluid path betweenthe vial 490 and the interior volume 482 of the first reservoir 410.Fluidic media may be drawn from the vial 490 through the needle 492 tothe interior volume 482 of the first reservoir 410 in a case where thevial 490 is connected to the first reservoir 410 and the first plungerhead 420 is moved within the first reservoir 410, for example away fromthe septum 440 of the first reservoir 410. The first plunger head 420may be moved within the first reservoir 410 to draw fluidic media fromthe vial 490, for example, by pulling on the handle 435.

Similarly, the second plunger head 470 may be moved within the secondreservoir 460, for example by pulling on the handle 435. In variousembodiments, the first plunger head 420 and the second plunger head 470may be configured to be moved simultaneously. Thus, for example, in suchembodiments, the first plunger head 420 and the second plunger head 470may be moved within the first reservoir 410 and the second reservoir470, respectively, by pulling on the handle 435.

In some embodiments, when the handle 435 is pulled to draw fluidic mediafrom the vial 490 to the interior volume 482 of the first reservoir 410,the membrane 452 and the passage 454 may allow for a transfer of airbubbles from the interior volume 482 of the first reservoir 410 to theinterior volume 486 of the second reservoir 460. The membrane 452 maysubstantially prevent a loss of fluidic media from the interior volume486 of the first reservoir 410 through the passage 454.

In some embodiments, the system 400 may include a second needle 495. Anend of the second needle 495 may be located within a headspace 497 ofthe vial 490 above fluidic media within the vial 490 in a case where thevial 490 is connected to the first reservoir 410 and the vial 490 isinverted. In other embodiments, the end of the second needle 495 may bein contact with fluidic media within the vial 490 in a case where thevial 490 is connected to the first reservoir 410.

An other end of the second needle 495 may be connected to a check valve494, such as a one-way valve, or the like. The check valve 494 may allowair to enter the vial 490 through the second needle 495. In someembodiments, the check valve 494 may substantially prevent fluidic mediafrom coming out of the vial 490 through the second needle 495 and/or thecheck valve 494. In various embodiments, the second needle 495 may allowfor venting the headspace 497 and/or the vial 490 to atmosphere tofacilitate transfer of fluidic media from the vial 490 to the interiorvolume 482 of the first reservoir 410.

In some embodiments, the second reservoir 460 may have a port 485 forexpelling air from the interior volume 486 of the second reservoir 460.Air in the interior volume 486 of the second reservoir 460 may beexpelled out the port 485 of the second reservoir 460 in a case wherethe interior volume 486 of the second reservoir 460 contains air and theinterior volume 486 of the second reservoir 460 is in communication withthe port 485 of the second reservoir 460. The port 485 of the secondreservoir 460 may be in communication with the interior volume 486 ofthe second reservoir 460 for example when the second plunger head 470has been sufficiently moved within the second reservoir 460, an exampleof which is illustrated in FIG. 1 OB.

FIGS. 11A-11C illustrate a cross-sectional view of a system 500 inaccordance with an embodiment of the present invention. The system 500may include, but is not limited to, an outer reservoir 510, an innerreservoir 560, a plunger head 570, a plunger arm 532, and a handle 535.The outer reservoir 510 may include a septum 540. The outer reservoir510 may have an interior volume 582 for containing fluidic media. Theinner reservoir 560 may be configured to be moveable in an axialdirection within the outer reservoir 510 to expand or contract theinterior volume 582 of the outer reservoir 510. The inner reservoir 560may include a membrane 552. The inner reservoir 560 may have an interiorvolume 586 that may be for containing a gas, such as, but is not limitedto, air, or the like.

The plunger head 570 may be configured to be moveable in an axialdirection within the inner reservoir 560 to expand or contract theinterior volume 586 of the inner reservoir 560. The plunger head 570 maybe connected to an end of the plunger arm 532. The plunger arm 532 mayextend through a back end 562 of the inner reservoir 560 and a back end512 of the outer reservoir 510 such that an end of the plunger arm 532opposite from the end of the plunger arm 532 connected to the plungerhead 570 may be connected to the handle 535. The handle 535 may be formoving at least one of the plunger head 570 and the inner reservoir 560.

A seal member 561, such as an o-ring, may be positioned between theinner reservoir 560 and the outer reservoir 510. The interior volume 582of the outer reservoir 510 may be on one side of the seal member 561.The outer reservoir 510 may have a chamber 584 located on an oppositeside of the seal member 561 from the interior volume 582 of the outerreservoir 510. The seal member 561 may be for substantially preventingfluidic media from flowing from the interior volume 582 of the outerreservoir 510 to the chamber 584 of the outer reservoir 510.

A seal member 571, such as an o-ring, may be positioned between theinner reservoir 560 and the plunger head 570. The interior volume 586 ofthe inner reservoir 560 may be on one side of the seal member 571. Theinner reservoir 560 may have a chamber 588 located on an opposite sideof the seal member 571 from the interior volume 586 of the innerreservoir 560. The seal member 571 may be for substantially preventingfluidic media from flowing from the interior volume 586 of the innerreservoir 560 to the chamber 588 of the inner reservoir 560.

The membrane 552 may be configured such that air may be able to passfrom the interior volume 582 of the outer reservoir 510 through themembrane 552 into the interior volume 586 of the second reservoir 560.Air may be able to pass through the membrane 552 in a case where fluidicmedia is in the interior volume 582 of the outer reservoir 510 and atleast one of the inner reservoir 560 and the plunger head 570 are movedaway from the vial 590.

In some embodiments, when the handle 535 is pulled to draw fluidic mediafrom the vial 590 to the interior volume 582 of the first reservoir 510,the membrane 552 may allow for a transfer of air bubbles from theinterior volume 582 of the first reservoir 510 to the interior volume586 of the second reservoir 560. The membrane 552 may substantiallyprevent a loss of fluidic media between the interior volume 582 of thefirst reservoir 510 and the interior volume 586 of the second reservoir560. The membrane 552 may comprise, for example, a hydrophobic material,or the like.

The system 500 may include a vial 590 and a needle 592. The vial 590 maybe for containing fluidic media. The septum 540 of the outer reservoir510 may be pierceable by the needle 592 to provide a fluid path betweenthe vial 590 and the interior volume 582 of the outer reservoir 510.

In some embodiments, the system 500 may include a second needle 595. Anend of the second needle 595 may be located within a headspace 597 ofthe vial 590 above fluidic media within the vial 590 in a case where thevial 590 is connected to the outer reservoir 510 and the vial 590 isinverted. In other embodiments, the end of the second needle 595 may bein contact with fluidic media within the vial 590 in a case where thevial 590 is connected to the outer reservoir 510.

Another end of the second needle 595 may be connected to a check valve594, such as a one-way valve, or the like. The check valve 594 may allowair to enter the vial 590 through the second needle 595. In someembodiments, the check valve 594 may substantially prevent fluidic mediafrom coming out of the vial 590 through the second needle 595 and/or thecheck valve 594. In various embodiments, the second needle 595 may allowfor venting the headspace 597 or the vial 590 to atmosphere tofacilitate the transfer of fluidic media from the vial 590 to theinterior volume 582 of the outer reservoir 510.

In operation of the system 500, according to one embodiment of thepresent invention, the vial 590 may be connected to the outer reservoir510 by way of the needle 592. The needle 592 may pierce the septum 540of the outer reservoir 510 to establish a fluid path between the vial590 and the interior volume 582 of the outer reservoir 510. Once thevial 590 is connected to the outer reservoir 510, the handle 535 may bepulled, for example away from the vial 590, to move the plunger head 570within the inner reservoir 560. As the plunger head 560 moves within theinner reservoir 560, for example away from the vial 590, the interiorvolume 586 of the inner reservoir 560 may increase, which may create avacuum within the interior volume 586 of the inner reservoir 560. Theplunger head 570 may be moved within the inner reservoir 560 until theplunger head 570 contacts the back end 562 of the inner reservoir 560 asillustrated in FIG. 11B.

Once the plunger head 570 contacts the back end 562 of the innerreservoir 560, further movement of the handle 535, for example away fromthe vial 590, may move the inner reservoir 560 within the outerreservoir 510 away from the vial 590 as illustrated in FIG. 11C. Thismay draw fluidic media from the vial 590 through the needle 592 into theinterior volume 582 of the outer reservoir 510. Air bubbles present influidic media in the interior volume 582 of the outer reservoir 510 maypass through the membrane 552 into the interior volume 586 of the innerreservoir 560.

FIGS. 12A and 12B illustrate a cross-sectional view of a system 600 inaccordance with an embodiment of the present invention. The system 600may include, but is not limited to, a first reservoir 610, a firstplunger head 620, a second reservoir 660, a second plunger head 670, anda membrane 652. The first plunger head 620 may be positioned within thefirst reservoir 610. The second plunger head 670 may be positionedwithin the second reservoir 660.

The first reservoir 610 may have a septum 640. The first reservoir 610may have an interior volume 682 for containing fluidic media on one sideof the first plunger head 620. The first reservoir 610 may have a firstchamber 684 on an opposite side of the first plunger head 620 from theinterior volume 682 of the first reservoir 610.

The second reservoir 660 may have an interior volume 686 on one side ofthe second plunger head 670. The interior volume 686 of the secondreservoir 660 may be for, but is not limited to, containing air, or thelike. The second reservoir 660 may have a second chamber 688 on anopposite side of the second plunger head 670 from the interior volume686 of the second reservoir 660.

The first plunger head 620 may be moveable in an axial direction withinthe first reservoir 610 to expand or contract the interior volume 682 ofthe first reservoir 610. Accordingly, a volume of the first chamber 684of the first reservoir 610 may contract while the interior volume 682 ofthe first reservoir 610 expands. The second plunger head 670 may bemoveable in an axial direction within the second reservoir 660 to expandor contract the interior volume 686 of the second reservoir 660.Accordingly, a volume of the second chamber 688 of the second reservoir660 may contract while the interior volume 686 of the second reservoir660 expands.

The first plunger head 620 may be connected to an end of a first plungerarm 630. The second plunger head 670 may be connected to an end of asecond plunger arm 632. The opposite ends of the first plunger arm 630and the second plunger arm 632 from those connected to the first plungerhead 620 and the second plunger head 670, respectively, may beoperatively connected to each other.

The first reservoir 610 and the second reservoir 660 may have a passage654 connecting the interior volume 682 of the first reservoir 610 andthe interior volume 686 of the second reservoir 660. The membrane 652may be positioned in the passage 654. The membrane 652 may be configuredsuch that air may be able to pass from the interior volume 682 of thefirst reservoir 610 through the passage 654 and the membrane 652 intothe interior volume 686 of the second reservoir 660. The membrane 652may comprise, for example, a hydrophobic material, or the like.

In some embodiments, the first plunger arm 630 and the second plungerarm 632 may be operatively connected to each other with gears forexample. In such embodiments, the system 600 may include a handle (notshown). The handle (not shown) may be operatively connected to ahalf-gear 635, for example. A first intermediate gear 634 may bepositioned on one side of the half-gear 635 and may be configured to beoperatively engagable to the half-gear 635. A second intermediate gear636 may be positioned on an other side of the half-gear 635 from theside of the half-gear 635 operatively engagable to the firstintermediate gear 634. The second intermediate gear 636 may beconfigured to be operatively engagable to the half-gear 635.

A first gear 633 may be positioned between the first intermediate gear634 and the first plunger arm 630 and may be configured to operativelyengage each of the first plunger arm 630 and the first intermediate gear634. A second gear 637 may be positioned between the second intermediategear 636 and the second plunger arm 632 and may be configured tooperatively engage each of the second plunger arm 632 and the secondintermediate gear 636. In other embodiments, any suitable configurationof gears may be used to operatively engage each of the first plunger arm630 and the second plunger arm 632.

The handle (not shown) and the half-gear 635 may be configured such thatthe half-gear 635 may be rotated as the handle (not shown) is rotated toengage one of the first intermediate gear 634 and the secondintermediate gear 636. For example, in a case where the handle (notshown) is rotated counter-clockwise, the half-gear 635 may be rotatedcounter-clockwise as well to operatively engage the first intermediategear 634. Once engaged, the half-gear 635 may then rotate the firstintermediate gear 634 in a clockwise direction, which may rotate thefirst gear 633 in a counter-clockwise direction. As the first gear 633rotates counter-clockwise, the first plunger arm 630 may be moved, forexample away from the vial 690. Movement of the first plunger arm 630and the first plunger head 620 attached to the first plunger arm 630 maycause fluidic media to be drawn from the vial 690 into the interiorvolume 682 of the first reservoir 610.

As another example, in a case where the handle (not shown) is rotatedclockwise, the half-gear 635 may be rotated clockwise as well tooperatively engage the second intermediate gear 636. Once engaged, thehalf-gear 635 may then rotate the second intermediate gear 636 in acounter-clockwise direction, which may rotate the second gear 637 in aclockwise direction. As the second gear 637 rotates clockwise, thesecond plunger arm 632 may be moved, for example away from the vial 690.Movement of the second plunger arm 632 and the second plunger head 670attached to the second plunger arm 632 may cause air bubbles in fluidicmedia contained in the interior volume 682 of the first reservoir 610 tomigrate through the passage 654 and the membrane 652 into the interiorvolume 686 of the second reservoir 660.

The system 600 may include a vial 690 and a needle 692. The vial 690 maybe for containing fluidic media. The septum 640 of the first reservoir610 may be pierceable by the needle 692 to provide a fluid path betweenthe vial 690 and the interior volume 682 of the first reservoir 610.Fluidic media may be drawn from the vial 690 through the needle 692 tothe interior volume 682 of the first reservoir 610 in a case where thevial 690 is connected to the first reservoir 610 and the first plungerhead 620 is moved within the first reservoir 610 away from the septum640 of the first reservoir 610. The first plunger head 620 may be movedwithin the first reservoir 610 to draw fluidic media from the vial 690,for example, by rotating or otherwise operating the handle (not shown).

Similarly, the second plunger head 670 may be moved within the secondreservoir 660, for example, by rotating or otherwise operating thehandle (not shown). Thus in some embodiments, the first plunger head 620and the second plunger head 670 may be moved within the first reservoir610 and the second reservoir 670, respectively, by rotating or otherwiserotating the handle (not shown).

In some embodiments, when the handle (not shown) is rotated or otherwiseoperated to draw fluidic media from the vial 690 to the interior volume682 of the first reservoir 610, the membrane 652 and the passage 654 mayallow for a transfer of air bubbles from the interior volume 682 of thefirst reservoir 610 to the interior volume 686 of the second reservoir660. The membrane 652 may substantially prevent a loss of fluidic mediafrom the interior volume 682 of the first reservoir 610 through thepassage 654.

In some embodiments, the system 600 may include a second needle 695. Anend of the second needle 695 may be located within a headspace 697 ofthe vial 690 above fluidic media within the vial 690 in a case where thevial 690 is connected to the first reservoir 610 and the vial isinverted 690. In other embodiments, the end of the second needle 695 maybe in contact with fluidic media within the vial 690 in a case where thevial 690 is connected to the first reservoir 610.

An other end of the second needle 695 may be connected to a check valve694, such as a one-way valve, or the like. The check valve 694 may allowair to enter the vial 690 through the second needle 695. In someembodiments, the check valve 694 may substantially prevent fluidic mediafrom coming out of the vial 690 through the second needle 695 and/or thecheck valve 694. In various embodiments, the second needle 695 may allowfor venting the headspace 697 and/or the vial 690 to atmosphere tofacilitate transfer of fluidic media from the vial 690 to the interiorvolume 682 of the first reservoir 610.

In some embodiments, the second reservoir 660 may have a port 685 forexpelling air from the interior volume 686 of the second reservoir 660.Air in the interior volume 686 of the second reservoir 660 may beexpelled out the port 685 of the second reservoir 660 in a case wherethe interior volume 686 of the second reservoir 660 contains air and theinterior volume 686 of the second reservoir 660 is in communication withthe port 685 of the second reservoir 660. The port 685 of the secondreservoir 660 may be in communication with the interior volume 686 ofthe second reservoir 660 for example, when the second plunger head 670has been sufficiently moved within the second reservoir 660. An exampleis illustrated in FIG. 10B, where the second plunger 470 has beensufficiently moved within the second reservoir 460 so that the port 485of the second reservoir 460 may be in communication with the interiorvolume 486 of the second reservoir 660.

FIGS. 13A-13C illustrate a cross-sectional view of a system 700 inaccordance with an embodiment of the present invention. The system 700may include, but is not limited to, an outer reservoir 710, an innerreservoir 760, and a handle 735. The outer reservoir 710 may include aseptum 740. The outer reservoir 710 may have an interior volume 782 forcontaining fluidic media. The inner reservoir 760 may be configured tobe moveable in an axial direction within the outer reservoir 710 toexpand or contract the interior volume 782 of the outer reservoir 710.The inner reservoir 760 may include a septum 762. The inner reservoir760 may have an interior volume 786 for containing a gas, which may be apressurized gas, such as compressed air, or the like. In someembodiments, the inner reservoir 760 may be a plunger head having aninterior volume 786.

The inner reservoir 760 may be connected to a handle 735. The handle 735may be for moving the inner reservoir 760 within the outer reservoir710. In other embodiments, the inner reservoir 760 may be connected toan end of a plunger arm (not shown). The plunger arm (not shown) mayextend through a back end of the outer reservoir 710 such that an end ofthe plunger arm (not shown) opposite from the end of the plunger arm(not shown) connected to the inner reservoir 760 may be connected to thehandle 735.

A seal member 761, such as an o-ring, may be positioned between theinner reservoir 760 and the outer reservoir 710. The interior volume 782of the outer reservoir 710 may be on one side of the seal member 761.The outer reservoir 710 may have a chamber 784 located on an oppositeside of the seal member 761 from the side of the seal member 761 incontact with the interior volume 782 of the outer reservoir 710. Theseal member 761 may be for substantially preventing fluidic media fromflowing from the interior volume 782 of the outer reservoir 710 to thechamber 784 of the outer reservoir 710.

The system 700 may include a vial 790 and a needle 792. The vial 790 maybe for containing fluidic media. The septum 740 of the outer reservoir710 may be pierceable by the needle 792 to provide a fluid path betweenthe vial 790 and the interior volume 782 of the outer reservoir 710 in acase where a first end 791 of the needle 792 is in the interior volume782 of the outer reservoir 710 and a second end 793 of the needle 792opposite from the first end 791 of the needle 792 is in the vial 790.

The septum 762 of the inner reservoir 760 may be pierceable by theneedle 792 to provide a path between the vial 790 and the interiorvolume 786 of the inner reservoir 760 in a case where the first end 791of the needle 792 is in the interior volume 786 of the inner reservoir760 and the second end 793 of the needle 792 is in the vial 790.

In various embodiments, pressure in the interior volume 786 of the innerreservoir 760 may be greater than pressure in the vial 790 prior to thevial 790 being connected to the outer reservoir 710 and the innerreservoir 760. Once connected, pressure in the interior volume 786 ofthe inner reservoir 760 and in the vial 790 may be substantiallyequalized relative to one another. Accordingly, pressure in the vial 790may be greater than pressure in the interior volume 782 of the outerreservoir 710. Thus when the inner reservoir 760 is moved within theouter reservoir 710 to allow the first end 791 of the needle 792 toenter the interior volume 782 of the outer reservoir 710 fluidic mediacontained in the vial 790 may flow into the interior volume 782 of theouter reservoir 710 in a case where the first end 791 of the needle 792is in the interior volume 782 of the outer reservoir 710 and pressure inthe vial 790 is greater than pressure in the interior volume 782 of theouter reservoir 710.

In operation of the system 700, according to an embodiment of thepresent invention, the vial 790 may be connected to the outer reservoir710 and the inner reservoir 760. The needle 792 may pierce the septum740 of the outer reservoir 710 and the septum 762 of the inner reservoirto establish a path between the vial 790 and the interior volume 786 ofthe inner reservoir 760. As a result, some of the pressurized gas, suchas, compressed air, contained in the interior volume 786 of the innerreservoir 760 may flow into the vial 790 in a case where the first end791 of the needle 792 is in the interior volume 786 of the innerreservoir 760 and pressure in the interior volume 786 of the innerreservoir 760 is greater than pressure in the vial 790.

The handle 735 may be pulled, for example away from the vial 790, tomove the inner reservoir 760 within the outer reservoir 710. The innerreservoir 760 may be moved within the outer reservoir 710 to a pointwhere the first end 791 of the needle 792 is in the interior volume 782of the outer reservoir 710 as illustrated in FIG. 13B.

Because pressure in the vial 790 has been increased from the compressedair contained in the interior volume 786 of the inner reservoir 760,pressure in the vial 790 may be greater than pressure in the interiorvolume 782 of the outer reservoir 710. Accordingly, fluidic media in thevial 790 may flow through the needle 792 into the interior volume 782 ofthe outer reservoir 710 in a case where the first end 791 of the needle792 is in the interior volume 782 of the outer reservoir 710 andpressure in the vial is greater than pressure in the interior volume 782of the outer reservoir 710.

In some embodiments, the handle 735 may continue to be pulled to movethe inner reservoir 760 within the outer reservoir 710, for example awayfrom the vial 790, such that the interior volume 782 of the outerreservoir 710 may increase and allow fluidic media to be drawn from thevial 790 through the needle 792 into the interior volume 782 of theouter reservoir 710 as illustrated in FIG. 13C. The inner reservoir 760may be moved within the outer reservoir 710 until the inner reservoir760 contacts a back end of the outer reservoir 710.

The embodiments disclosed herein are to be considered in all respects asillustrative, and not restrictive of the invention. The presentinvention is in no way limited to the embodiments described above.Various modifications and changes may be made to the embodiments withoutdeparting from the spirit and scope of the invention. The scope of theinvention is indicated by the attached claims, rather than theembodiments. Various modifications and changes that come within themeaning and range of equivalency of the claims are intended to be withinthe scope of the invention.

1. A system for managing air bubbles, the system comprising: a reservoirhaving a wall defining an interior volume for containing fluidic media,the reservoir having a port for expelling fluidic media from theinterior volume of the reservoir, the wall of the reservoir defining oneor more air passages that extend out of the interior volume of thereservoir through the wall of the reservoir; a plunger head moveablewithin the reservoir, the plunger head arranged such that the interiorvolume of the reservoir is on one side of the plunger head and a chamberof the reservoir is on an opposite side of the plunger head from theinterior volume of the reservoir, the plunger head in contact withfluidic media when fluidic media is in the interior volume of thereservoir; and one or more filters, each of the one or more filterslocated in a respective air passage of the one or more air passages,each of the one or more filters configured to allow air in the interiorvolume of the reservoir to pass through the filter and to exit thereservoir through the respective air passage of the one or more airpassages as the plunger head moves within the reservoir to expel fluidicmedia from the interior volume of the reservoir out the port of thereservoir.
 2. The system of claim 1, wherein the one or more airpassages extend from the interior volume of the reservoir to an outersurface of the reservoir.
 3. The system of claim 2, wherein each of theone or more filters are located at an end of the respective air passageof the one or more air passages.
 4. The system of claim 3, wherein eachof the one or more filters comprises a hydrophobic material; and whereineach of the one or more filters is positioned at the end of therespective air passage of the one or more air passages so as tosubstantially prevent fluidic media from entering the respective airpassage of the one or more air passages in a case where fluidic media isin the interior volume of the reservoir.
 5. The system of claim 2, thereservoir having a fluid channel that leads from the interior volume ofthe reservoir to the port of the reservoir; wherein the one or more airpassages surround the fluid channel of the reservoir.
 6. The system ofclaim 2, wherein each of the one or more air passages exits thereservoir on a same side of the reservoir where the port of thereservoir is located.
 7. The system of claim 2, wherein each of the oneor more air passages allows air to exit the reservoir on a same side ofthe reservoir where fluidic media is expelled from the reservoir.
 8. Amethod of making a system for managing air bubbles, the methodcomprising: providing a reservoir having a wall defining an interiorvolume for containing fluidic media, the reservoir having a port forexpelling fluidic media from the interior volume of the reservoir, thewall of the reservoir defining one or more air passages that extend outof the interior volume of the reservoir through the wall of thereservoir; arranging a plunger head moveable within the reservoir, theplunger head arranged such that the interior volume of the reservoir ison one side of the plunger head and a chamber of the reservoir is on anopposite side of the plunger head from the interior volume of thereservoir, the plunger head in contact with fluidic media when fluidicmedia is in the interior volume of the reservoir; and locating each ofone or more filters in a respective air passage of the one or more airpassages, each of the one or more filters configured to allow air in theinterior volume of the reservoir to pass through the filter and to exitthe reservoir through the respective air passage of the one or more airpassages as the plunger head moves within the reservoir to expel fluidicmedia from the interior volume of the reservoir out the port of thereservoir.
 9. The system of claim 1, wherein the one or more airpassages connect the interior volume of the reservoir with the chamberof the reservoir; and wherein each of the one or more filters is forallowing air to pass from the interior volume of the reservoir to thechamber of the reservoir through the respective air passage of the oneor more air passages of the reservoir and for inhibiting fluidic mediafrom passing from the interior volume of the reservoir to the chamber ofthe reservoir through the respective air passage of the one or more airpassages of the reservoir.
 10. The system of claim 9, furthercomprising: a bias member connected between a surface of the reservoirand the plunger head within the chamber of the reservoir.
 11. The systemof claim 10, wherein the bias member comprises a spring.
 12. The systemof claim 9, further comprising: a valve for allowing a vacuum to beapplied to the chamber of the reservoir.
 13. The system of claim 9,wherein each of the one or more filters is a membrane comprising ahydrophobic material.
 14. The system of claim 9: wherein the one or moreair passages connect the interior volume of the reservoir with thechamber of the reservoir; and wherein each of the one or more filters isfor allowing air to pass from the interior volume of the reservoir tothe chamber of the reservoir through the respective air passage of theone or more air passages of the reservoir and for inhibiting fluidicmedia from passing from the interior volume of the reservoir to thechamber of the reservoir through the respective air passage of the oneor more air passages of the reservoir.
 15. A system of managing airbubbles, the system comprising: a reservoir having an interior volumefor containing fluidic media, the reservoir having a port for expellingfluidic media from the interior volume of the reservoir, the reservoirhaving one or more air passages that extend out of the interior volumeof the reservoir; a plunger head moveable within the reservoir, theplunger head arranged such that the interior volume of the reservoir ison one side of the plunger head and a chamber of the reservoir is on anopposite side of the plunger head from the interior volume of thereservoir; one or more filters, each of the one or more filters locatedin a respective air passage of the one or more air passages; and abellows member arranged in the chamber of the reservoir, the bellowsmember connected to the plunger head; wherein the one or more airpassages is arranged in the plunger head from a first surface of theplunger head to a second surface of the plunger head, the first surfaceof the plunger head in contact with fluidic media in a case wherefluidic media is in the interior volume of the reservoir; and whereineach of the one or more filter is located within the respective airpassage of the one or more air passages of the plunger head, each of theone or more filters configured to allow air to pass from the interiorvolume of the reservoir to an interior volume of the bellows memberthrough the respective air passage of the one or more air passages ofthe plunger head, each of the one or more filters configured to inhibitfluidic media from passing from the interior volume of the reservoir tothe interior volume of the bellows member through the respective airpassage of the one or more air passages of the plunger head in a casewhere fluidic media is in the interior volume of the reservoir.
 16. Amethod of making a system for managing air bubbles, the methodcomprising: providing a reservoir having an interior volume forcontaining fluidic media, the reservoir having a port for expellingfluidic media from the interior volume of the reservoir, the reservoirhaving one or more air passages that extend out of the interior volumeof the reservoir; arranging a plunger head moveable within thereservoir, the plunger head arranged such that the interior volume ofthe reservoir is on one side of the plunger head and a chamber of thereservoir is on an opposite side of the plunger head from the interiorvolume of the reservoir; locating each of one or more filters in arespective air passage of the one or more air passages; arranging abellows member in the chamber of the reservoir; and connecting thebellows member to the plunger head; wherein the one or more air passagesare arranged in the plunger head from a first surface of the plungerhead to a second surface of the plunger head, the first surface of theplunger head in contact with fluidic media in a case where fluidic mediais in the interior volume of the reservoir; and wherein each of the oneor more filters is configured to allow air to pass from the interiorvolume of the reservoir to an interior volume of the bellows memberthrough the respective air passage of the one or more air passages ofthe plunger head, each of the one or more filters configured to inhibitfluidic media from passing from the interior volume of the reservoir tothe interior volume of the bellows member through the respective airpassage of the one or more air passages of the plunger head in a casewhere fluidic media is in the interior volume of the reservoir.
 17. Thesystem of claim 1, the system comprising: a second reservoir having aninterior volume for containing air, the one or more air passagesarranged to connect the interior volume of the reservoir and theinterior volume of the second reservoir; and a second plunger headmoveable within the second reservoir; wherein each of the one or morefilters is for allowing air to pass from the interior volume of thefirst reservoir to the interior volume of the second reservoir throughthe respective air passage of the one or more air passages and forinhibiting fluidic media from passing from the interior volume of thereservoir to the interior volume of the second reservoir through therespective air passage of the one or more air passages.
 18. The systemof claim 17, wherein the plunger head and the second plunger head areconfigured to move substantially simultaneously.
 19. The system of claim17, the second plunger head operatively connected to the plunger head.20. The system of claim 17, the reservoir having a septum, the septumpierceable by a needle for providing a fluid path between a vialcontaining fluidic media and the interior volume of the reservoir. 21.The system of claim 20, the plunger head moveable within the reservoirbetween at least a first position and a second position; the plungerhead for drawing fluidic media from the vial into the interior volume ofthe reservoir in a case where the vial is connected to the reservoir andthe plunger head is moved to the second position of the plunger head.22. The system of claim 20, the second plunger head moveable within thesecond reservoir between at least a first position and a secondposition; wherein each of the one or more air filters is configured toallow air to pass from the interior volume of the first reservoirthrough the respective air passage of the one or more air passages tothe interior volume of the second reservoir in a case where air is inthe interior volume of the first reservoir and the second plunger headis moved to the second position of the second plunger head.
 23. Thesystem of claim 17, the interior volume of the second reservoir locatedon one side of the second plunger head; the second reservoir having achamber on an opposite side of the second plunger head from the interiorvolume of the second reservoir; the second reservoir having a port forexpelling air from the interior volume of the second reservoir in a casewhere the interior volume of the second reservoir contains air and theport of the second reservoir and the interior volume of the secondreservoir are in communication.
 24. The system of claim 17, wherein eachof the one or more filters is membrane comprising a hydrophobicmembrane.
 25. The method of claim 8, the method comprising: providing asecond reservoir having an interior volume for containing air; the oneor more air passages to connect the interior volume of the reservoir andthe interior volume of the second reservoir; and; locating a secondplunger head moveable within the second reservoir; each of the one ormore filters for allowing air to pass from the interior volume of thereservoir to the interior volume of the second reservoir through therespective air passage of the one or more air passages and forinhibiting fluidic media from passing from the interior volume of thereservoir to the interior volume of the second reservoir through therespective air passage of the one or more air passages.
 26. The systemof claim 1, the system comprising: an inner reservoir having an interiorvolume, at least a portion of the inner reservoir configured to bemoveable in the reservoir, the one or more air passages connecting theinterior volume of the reservoir and the interior volume of the innerreservoir; the plunger head moveable within the inner reservoir; whereineach of the one or more filters is for allowing air to pass from theinterior volume of the reservoir to the interior volume of the innerreservoir through the respective air passage of the one or more airpassages and for inhibiting fluidic media from passing from the interiorvolume of the reservoir to the interior volume of the inner reservoirthrough the respective air passage of the one or more air passages. 27.The system of claim 26, the plunger head moveable within the innerreservoir between at least a first plunger position and a second plungerposition; wherein a vacuum in the interior volume of the inner reservoiris created when the plunger head is moved from the first plungerposition to the second plunger position.
 28. The system of claim 27, thereservoir having a septum, the septum pierceable by a needle, the needlefor providing a fluid path from a vial containing fluidic media to theinterior volume of the reservoir.
 29. The system of claim 28, the innerreservoir configured to be moveable in the reservoir between at least afirst inner reservoir position and a second inner reservoir position;wherein fluidic media is drawn from the vial into the interior volume ofthe reservoir in a case where the interior volume of the reservoir is influid communication with the vial and the inner reservoir is moved fromthe first inner reservoir position to the second inner reservoirposition.
 30. The system of claim 26, wherein each of the one or morefilters is a membrane comprising a hydrophobic filter.
 31. The method ofclaim 9, the method comprising: providing an inner reservoir having aninterior volume, at least a portion of the inner reservoir configured tobe moveable in the reservoir; arranging the one or more air passages toconnect the interior volume of the reservoir and the interior volume ofthe inner reservoir; the plunger head moveable within the innerreservoir; each of the one or more filters for allowing air to pass fromthe interior volume of the reservoir to the interior volume of the innerreservoir through the respective air passage of the one or more airpassages and for inhibiting fluidic media from passing from the interiorvolume of the reservoir to the interior volume of the inner reservoirthrough the respective air passage of the one or more air passages. 32.The system of claim 1, wherein the plunger head is moveable within thereservoir relative to the one or more air passages as fluidic media isexpelled from the interior volume of the reservoir out the port of thereservoir.
 33. The system of claim 1, each of the one or more filtersconfigured to allow air in the interior volume of the reservoir to passthrough the filter and to exit the reservoir through the respective airpassage of the one or more air passages as the plunger head moves,relative to the one or more filters, within the reservoir to expelfluidic media from the interior volume of the reservoir out the port ofthe reservoir.
 34. The system of claim 1, the plunger head moveablewithin the reservoir along an axial dimension of the reservoir, each ofthe one or more filters having an axial dimension transverse the axialdimension of the reservoir.
 35. The system of claim 1, wherein the portof the reservoir comprises the one or more air passages.